STERILE WATER- water injection, solution

Sterile Water by

Drug Labeling and Warnings

Sterile Water by is a Prescription medication manufactured, distributed, or labeled by American Regent, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

BOXED WARNING

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NOT FOR DIRECT INJECTION

DESCRIPTION:

Sterile Water for Injection, USP is water for injection sterilized and packaged in single dose vials. It contains no antimicrobial agents or other preservatives. It is used as a diluent. Non-pyrogenic.

PRECAUTIONS:

Unused amount should be discarded immediately following withdrawal of any portion of vial contents. Sterile Water for Injection is not isotonic and should not be injected directly into the body.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

HOW SUPPLIED:

Sterile Water for Injection, USP

NDC: 0517-3005-25	5 mL Single Dose Vial	Packaged in 25
NDC: 0517-3010-25	10 mL Single Dose Vial	Packaged in 25
NDC: 0517-3020-25	20 mL Single Dose Vial	Packaged in 25
NDC: 0517-3050-25	50 mL Single Dose Vial	Packaged in 25

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN3005
Rev. 1/09

PRINCIPAL DISPLAY PANEL - 5 mL

Contain

NDC: 0517-3005-01

STERILE WATER
FOR INJECTION, USP

5 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967




Carton

STERILE WATER
FOR INJECTION, USP

NDC: 0517-3005-25
25 x 5 mL
SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05

PRINCIPAL DISPLAY PANEL - 10 mL

Container

NDC: 0517-3010-01

STERILE WATER
FOR INJECTION, USP

10 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967



Carton

STERILE WATER
FOR INJECTION, USP

NDC: 0517-3010-25
25 x 10 mL
SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05

PRINCIPAL DISPLAY PANEL - 20 mL

Container

NDC: 0517-3020-01

STERILE WATER
FOR INJECTION, USP

20 mL SINGLE DOSE VIAL

FOR DRUG DILUENT USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Carton

STERILE WATER
FOR INJECTION, USP

NDC: 0517-3020-25
25 x 20 mL
SINGLE DOSE VIALS

FOR DRUG DILUENT USE

Rx Only

No antimicrobial or other substance has been added. For use as a vehicle, solvent, or diluent for substances to be administered parenterally. Must be made approximately isotonic before intravenous use. Sterile, nonpyrogenic.
WARNING: DISCARD UNUSED PORTION.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 5/18

Serialization Label - 5 mL

Serialization Label - 10 mL

Serialization Label - 20 mL

INGREDIENTS AND APPEARANCE

STERILE WATER 
water injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0517-3005
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0517-3005-25	25 in 1 TRAY	09/30/1990
1	NDC: 0517-3005-01	5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		09/30/1990

STERILE WATER 
water injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0517-3010
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0517-3010-25	25 in 1 TRAY	01/25/1999
1	NDC: 0517-3010-01	10 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/25/1999

STERILE WATER 
water injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0517-3020
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	1 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0517-3020-25	25 in 1 TRAY	09/03/1996
1	NDC: 0517-3020-01	20 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		09/03/1996

Labeler - American Regent, Inc. (002033710)

Establishment
Name	Address	ID/FEI	Business Operations
American Regent, Inc.		002033710	ANALYSIS(0517-3005, 0517-3010, 0517-3020) , MANUFACTURE(0517-3005, 0517-3010, 0517-3020) , STERILIZE(0517-3005, 0517-3010, 0517-3020)